HIV Clinical Trial
— PESUOfficial title:
The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes
Verified date | October 2018 |
Source | University of Zimbabwe |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Youth with evidence of virologic failure defined as an HIV VL>400 copies/mL on two consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression.
Status | Completed |
Enrollment | 214 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 24 Years |
Eligibility |
Inclusion Criteria: - Documented HIV positive - Age > 10 years and = 24 years - Two consecutive HIV VL>400 copies/mL, at least one month apart - Residence within 50 km of Harare - Able to provide written informed consent (age 18 or older) or assent (age <18 years) Exclusion Criteria: - Inability to provide informed consent or assent - Past or current involvement in the Zvandiri Intervention Program |
Country | Name | City | State |
---|---|---|---|
Zimbabwe | Parirenyatwa Hospital | Harare |
Lead Sponsor | Collaborator |
---|---|
University of Zimbabwe |
Zimbabwe,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Virologic suppression rate in the Peer Support Intervention i group compared with the standard of care group following 48 weeks in the Peer Support Intervention. | Virologic suppression | 2 years | |
Secondary | Frequency of acquired drug resistance mutations among youth failing ART. | drug resistance mutations | 2 years | |
Secondary | Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy | psychological distress | 2 years | |
Secondary | Prevalence of psychological distress (measured using PHQ-A and SSQ) after 48 weeks of enrolment in the Peer Support Intervention compared with the standard of care | psychological distress | 2 years | |
Secondary | Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations). | (viral load), DBS and hair (tenofovir concentrations). | 2 years | |
Secondary | Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques. | detection of drug resistance | 2 years |
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